Catalog Number 6541-4-809 |
Device Problems
Break (1069); Entrapment of Device (1212); Difficult to Remove (1528); Material Integrity Problem (2978); Scratched Material (3020)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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Event Date 03/12/2015 |
Event Type
malfunction
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Event Description
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Reused fluted headless pin became stuck on tibial cutting block and staff then broke pin inside triathlon pin driver.
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Manufacturer Narrative
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Review of the device history records indicates the lot was manufactured and accepted into final stock on 22-jan-2014.There have been no other events for the lot referenced.The device was returned with the broken hex end of the headless pin still in place and could not be removed.The event was confirmed.The event was confirmed as the tip of the pin was still in the headless pin driver.However the root cause could not be determined as the events leading to the fracture of the pin could not be replicated with the returned parts.No further investigation for this event is possible at this time as insufficient information was received by stryker orthopaedics.If additional information becomes available, this investigation will be reopened.
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Event Description
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Reused fluted headless pin became stuck on tibial cutting block and staff then broke pin inside triathlon pin driver.
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Search Alerts/Recalls
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